S02 - Attachment 38 - Numbered Memorandum 119-30-18 Anticoagulation Management Program.docx

20. April 02, 2018 Numbered Memorandum 119-30-18

ANTICOAGULATION MANAGEMENT PROGRAM

1. PURPOSE: To define policy and procedures for providing high-quality, evidence-based medication management and standardization of care for patients receiving anticoagulants at Mann-Grandstaff Veterans Affairs Medical Center (MGVAMC).

2. POLICY:

a. The MGVAMC anticoagulation management program coordinates anticoagulation medication management across inpatient, Community Living Center (CLC), and outpatient clinic settings to support continuity of care, achieve maximum therapeutic effectiveness, and reduce the likelihood of harm for patients receiving anticoagulants.

b. Anticoagulation therapy is individualized for each patient, using standardized evidence-based processes, algorithms, and guidelines to support desired outcomes and reduce the risk of adverse drug events (ADEs) associated with the use of anticoagulants.

c. All patients receiving warfarin, direct oral anticoagulants (DOACs), or long-term parenteral anticoagulants from MGVAMC anticoagulation providers, will be managed following the policies and procedures outlined in the MGVAMC anticoagulation management program.

d. Laboratory monitoring, quality assurance, and reporting will be conducted using standardized procedures to ensure accuracy of test results and retrievability of information.

e. Anticoagulants are included on the MGVAMC list of high-alert medications, with safeguards in place to support safe storage, ordering, dispensing, and administration across the facility.

f. Processes are in place to reduce the risk associated with incorrect tablet strength dosing errors with warfarin such as limiting the strengths that can be prescribed.

g. All international normalized ratio (INR) results will be evaluated, with appropriate clinical action and follow-up completed, documented, and communicated in accordance with established time frames.

h. During normal business hours, the anticoagulation management program will have a direct telephone extension, which is accessible to facility staff and anticoagulation patients.

i. Critical drug-drug interactions with anticoagulant medications will be addressed with defined roles and responsibilities to ensure appropriate follow-up.

j. Anticoagulation management is coordinated for traveling patients prescribed anticoagulants in accordance with Veterans Health Administration (VHA) Handbook 1101.11 and Numbered Memorandum (NM) 119-24-16, Pharmacists Support for Traveling Veterans, to minimize patient loss to follow-up.

k. Prescriptions for anticoagulation therapy ordered (e.g., orders entered into Computerized Patient Record System (CPRS) by a clinical pharmacy specialist [CPS]) must be checked and verified by a different clinical pharmacist during the outpatient pharmacy review process, prior to the prescription being dispensed.

3. DEFINITIONS:

a. Algorithm: Standardized care process, which outlines steps used to manage a patient’s anticoagulation therapy, and utilized across the facility. Algorithms must be evidence-based, approved by the Pharmacy, Therapeutics and Nutrition (PT&N) Committee, and the Clinical Executive Council (CEC), and must follow the guidance included in VHA Directive 1033. An algorithm may contain protocols, which are outlined in the policy, that outline specific actions to be implemented based on patient parameters by designated individuals for anticoagulation patient care management (e.g., unfractionated heparin and argatroban protocols by nursing staff). Any actions or processes outlined in algorithms or protocols must be within the scope of practice (or in policy) of the individual performing the function.

b. Ancillary testing: Laboratory testing or services performed within a Department of Veterans Affairs (VA) medical center or its outreach functions (clinic, et al.), but outside the physical facilities of the main clinical laboratory. It is often referred to as point-of-care testing (POCT).

c. Anticoagulant: Medication that inhibits blood coagulation. Anticoagulants include, but are not limited to, warfarin, unfractionated heparin, low molecular weight heparin, other parenteral anticoagulants (e.g., fondaparinux, argatroban), and DOACs such as edoxaban, dabigatran, rivaroxaban, or apixaban. The term “anticoagulant” refers to anticoagulation therapy or long-term anticoagulation prophylaxis (e.g., atrial fibrillation) and does not include routine situations in which short-term prophylactic anticoagulation is used for venous thromboembolism prevention (e.g., related to procedures or hospitalization). In addition, medications whose primary purpose is to inhibit platelet function (e.g. aspirin, clopidogrel, prasugrel) are not included under this definition.

d. Anticoagulation management program: Coordinated program where anticoagulation providers manage anticoagulants for inpatients within the facility and outpatients through enrollment in the centralized anticoagulation clinic. In addition to the clinical practice aspect, the program also encompasses broader functions including coordinating policy and quality assurance relevant to anticoagulation management at the facility, and will serve as the primary resource for anticoagulation questions and concerns from the medical staff.

e. Anticoagulation provider: CPSs, who are currently trained and skilled in managing anticoagulant therapy. The anticoagulation provider is an active member of the anticoagulation management program, responsible for monitoring the quality of his or her clinical practice, and has prescriptive authority defined in their scope of practice that includes anticoagulants. These individuals serve as consultants to other providers.

f. Anticoagulation management champion: Physician appointed by the Chief of Staff (COS) to be actively involved and serve collaboratively with the anticoagulation program manager to advocate for, provide consultation on anticoagulation issues, and support anticoagulation initiatives at the facility level.

g. Anticoagulation program manager: Anticoagulation provider that serves as a leader for the anticoagulation management program and is responsible for ensuring that the program meets elements of performance defined in VHA directive 1033, the Joint Commission (TJC), and National Patient Safety Goals. This individual maintains a high standard for continuing education in the area of anticoagulation therapy and serves as a local subject matter expert regarding anticoagulation management. The anticoagulation program manager collaborates with other services to ensure that the anticoagulation management program meets all standards outlined in this policy.

h. Anticoagulation support staff: Group of professionals assigned to the anticoagulation management program that perform day-to-day operational support functions. Anticoagulation support staff may include, but are not limited to, pharmacy technicians, nurses, health technicians, and clerical associates. Anticoagulation support staff may assist with many of the technical issues associated with the anticoagulation management program under the supervision of an anticoagulation provider. Responsibilities may include, but are not limited to, answering and triaging patient telephone calls, contacting patients who have missed appointments, sending letters to patients, communicating with outside laboratories, and other similar tasks.

i. Bridge therapy: Temporary use of a short and immediate acting injectable anticoagulant (usually a heparin) during periods when the INR level is sub-therapeutic (e.g., when warfarin therapy is started) or when warfarin is being held to perform invasive procedures (peri-procedural bridging).

j. Continuity VA provider: MGVAMC credentialed community based outpatient clinic (CBOC), primary care, home based primary care (HBPC), rural health clinic (RHC) or sub-specialty providers. A continuity VA provider supports patient enrollment into the anticoagulation management program and is responsible for collaborating with the anticoagulation management program to oversee anticoagulation.

k. Prescribing VA provider: MGVAMC credentialed providers prescribing anticoagulants in inpatient or other hospital locations but who will not serve as continuity VA providers. A safe transition of care for patients prescribed anticoagulants is expected between prescribing VA providers, continuity VA providers, anticoagulation program providers, and non-MGVAMC providers, including other VA and community care providers.

l. Geometric mean of the prothrombin time (PT): Calculation of the mean PT for the laboratory patient population using the current thromboplastin reagent. It is used to calculate the INR.

m. INR: Standardized measure of the PT, which is used to determine the clotting tendency of blood for a patient receiving warfarin therapy. The INR is the ratio of a patient's PT to a normal (control) sample, raised to the power of the International Sensitivity Index (ISI) value for the reagent system used.

n. Critical INR value: MGVAMC Pathology and Laboratory Medicine Service has defined an INR value of > 5 as “critical” for samples obtained by venipuncture, which is listed in the laboratory Veterans Health Information Systems and Technology Architecture (VistA) software package.

o. ISI: Measure of thromboplastin sensitivity to an international standard. Each lot number of thromboplastin used in prothrombin or INR testing is assigned its own unique ISI value from the manufacturer.

p. Inpatient: Patient care areas including, medical surgical wards, acute care/intensive care units, and psychiatry. It will also refer to patients being cared for in the emergency department/urgent care center (ED/UCC) with a planned admission to another aforementioned inpatient area.

q. CLC: Patient care areas including long-term care, rehabilitation, hospice, and palliative care.

r. Outpatient: Patients actively enrolled with patient aligned care team (PACT), CBOCs, RHCs, HBPC, or MGVAMC mobile clinic. Outpatients whose anticoagulation is prescribed by a non-VA health system or non-VA health provider under authority of the Veterans’ Access, Choice and Accountability Act (Choice Program) or nursing home provider will not be enrolled in MGVAMC’s anticoagulation management program.

s. Therapeutic anticoagulation: Use of anticoagulants in a manner expected to alter laboratory values reflecting the state of anticoagulation in a prescribed range based on most current American College of Chest Physicians guidelines.

4. PROCEDURES:

a. Standard operating procedures (SOPs), algorithms, and practice guidelines for managing anticoagulation therapy have been developed using evidence-based treatment recommendations to support clinical decision making across the continuum of care. Practice guidelines are not intended to supersede clinical judgement. Deviations from dosing guidelines should be documented in the patient chart.

(1) All providers, nurses, and pharmacists will be notified of new or revised anticoagulation protocols, procedures, and practice guidelines via facility wide distribution and will be offered in-service training in the case of significant change(s).

(2) Active versions of all MGVAMC anticoagulation protocols, procedures, and practice guidelines are available to all medical staff on MGVAMC’s SharePoint and supported by CPRS ordering menus, as applicable.

(a) Initiation of warfarin algorithm;

(b) Maintenance of warfarin algorithm;

(c) Guidance for direct oral anticoagulants;

(d) Guidance for peri-procedural management of anticoagulants;

(e) Use of weight-based, unfractionated heparin nursing protocol;

(f) Management of bleeding in patients receiving anticoagulants;

(g) Discontinuing warfarin therapy;

(h) Argatroban nursing protocol; and

(i) Anticoagulation clinic patient agreement.

b. The anticoagulation program manager will use multiple resources, including, but not limited to, MGVAMC quality assurance data, VHA Pharmacy Benefit Management (PBM) alerts, Food and Drug Administration (FDA) alerts, national clinical practice guidelines, primary literature, and shared best practices to identify improvement opportunities and propose revisions or additions to existing protocols, procedures, practice guidelines and/or medication ordering menus. Any member of the medical or quality assurance staff may suggest updates to the anticoagulation policy, procedures, and practice guidelines via direct contact with the anticoagulation program manager, anticoagulation management champion, or clinical pharmacy supervisor.

c. Laboratory monitoring and evaluation: Laboratory monitoring will be conducted using standardized procedures to ensure accuracy of results and retrievability of information. All laboratory monitoring will be documented in CPRS. This includes INR values received from other VA facilities and non-VA laboratories used to monitor and adjust anticoagulation therapy. Baseline and ongoing laboratory monitoring will be used to individualize the dose of anticoagulant to achieve desired outcomes.

(1) Recommended baseline laboratory testing for selected anticoagulants:

(a) Unfractionated intravenous (IV) heparin drip: Complete blood count (CBC) with platelets, INR, and partial thromboplastin time (PTT) per patient care services nursing protocol.

(b) Low molecular weight heparin and factor-Xa (fondaparinux) inhibitors: CBC with platelets, PT/aPTT, and serum creatinine.

(c) Warfarin: CBC with platelets, PT, and INR.

(d) DOAC: CBC with platelets, serum creatinine, and liver function tests (LFTs).

(e) Argatroban: PTT, INR, LFTs, and CBC with platelets per patient care services nursing protocol.

(2) Recommended ongoing laboratory testing for selected anticoagulants:

(a) Unfractionated IV heparin drip: hemoglobin (HGB), hematocrit (HCT), platelet count, and PTT per patient care services nursing protocol. Anti-factor Xa levels may be considered on an as needed basis, when clinically indicated.

(b) Low molecular weight heparin and factor-Xa inhibitors (fondaparinux): CBC with platelets and serum creatinine periodically.

(c) Warfarin: CBC with platelets, PT, and INR. Frequency of ordering these labs will be consistent with nationally recognized evidence-based and/or “best practice” guidelines.

(d) DOAC: CBC and serum creatinine.

(e) Argatroban: PTT per patient care services nursing protocol.

(3) Laboratory tests for anticoagulation management will preferably be performed at a VA laboratory, to ensure accuracy of results and retrievability of information. If non-VA laboratory results are received, the anticoagulation provider will record the INR in a current progress note along with the name and contact information of the laboratory reporting the result and the date the lab was drawn and processed.

(4) Communicating outpatient test results to patients: Lab monitoring results will be evaluated and communicated to the patient, in accordance with facility policy and VHA Directive 1088, “Communicating Test Results to Providers and Patients”.

(a) INR results must be evaluated by the close of the next regular business day. Communication of therapeutic INR results must be completed and documented in the electronic medical record within seven days of INR receipt.

(b) Critical INR results (INR >5) must be evaluated within 24 hours. Documentation of appropriate action taken to address the critical INR must be entered in the electronic medical record within 24 hours of the critical lab result.

d. Staff education: The anticoagulation program manager facilitates anticoagulation education for anticoagulation providers and clinical staff directly involved in caring for patients receiving anticoagulation therapy, as appropriate. Education may include:

(1) The results of the anticoagulation quality assurance program and performance improvement activities, as appropriate;

(2) Academic detailing based on locally identified learning needs, new algorithms, guidelines, or policies, emerging information regarding anticoagulants, or anticoagulation topics identified as important to the facility;

(3) VA educational programs available for staff education; and

(4) Academic detailing provided in forums such as staff meetings, newsletters, rounds, external programs, Talent Management System (TMS), or other venues.

e. Quality assurance:

(1) Continuous evaluation of anticoagulation safety practices will be conducted by the anticoagulation program manager via data collection and analysis. Internal and external data streams will be systematically examined to identify improvement opportunities, prioritize work, develop action plans, and evaluate if implemented improvement actions have resulted in sustained achievement of desired results. Barriers to improvement actions will be elevated accordingly through the PT&N committee and/or Patient Safety Manager to CEC, as appropriate.

(2) The anticoagulation program manager will prepare a quality assurance report for the outpatient anticoagulation clinic. The report will be presented to the PT&N Committee on a quarterly basis. Any identified issues discovered during the quality assurance process will be tracked and trended by the facility anticoagulation program manager and reported through the PT&N committee to the CEC. Quality assurance measures will include, at a minimum:

(a) Patients taking warfarin not having INR within 42 days in the outpatient clinic;

(b) ADEs involving anticoagulants;

(c) Tracking and trending total time in therapeutic range at the National, Veteran Integrated Service Network (VISN), and facility levels;

(d) Patients with pathological bleeding events;

(e) Patients with thromboembolic events;

(f) Patient incidents, close calls, and near misses associated with an anticoagulant; and

(g) Medication use evaluation tracker data DOAC.

(3) Professional Practice Evaluations: All clinical pharmacy specialists with a scope of practice, and prescribing authority for anticoagulants will participate in a professional practice evaluation program. The professional practice evaluation program is comprised of focused professional practice evaluation (FPPE) and ongoing professional practice evaluation (OPPE) as described in VHA Handbook 1108.11. Professional practice evaluations are an organized review deigned to contribute to improving the quality of care and appropriate utilization or health care resources. Identified concerns with quality or competency will be promptly addressed with the anticoagulation provider to support improvement. The professional practice evaluation program follows medical staff bylaws and reports to the Executive Committee of the Medical Staff (ECMS). Competency assessment will include, at a minimum:

(a) Knowledge of standard terminology;

(b) Pharmacology of anticoagulants;

(c) Monitoring requirements;

(d) Dose calculations;

(e) Common side effects; and

(f) Anticoagulant-nutrient interactions.

f. Medication management processes: Safe medication management processes are in place to reduce the likelihood of harm for patients receiving anticoagulants for inpatients and outpatients.

(1) Anticoagulants are included on the medical facility’s list of high alert medications with safeguards in place to support safe storage, ordering, dispensing, and administration across the facility.

(a) Only oral unit dose products, pre-filled syringes, or pre-mixed infusion bags for anticoagulants are dispensed for inpatients when these types of products are available.

(b) The number of concentrations and quantities of heparin vials stocked in patient care and procedural areas are limited to the minimum amount needed to meet patient care needs.

(c) No multi-dose heparin product more concentrated than 5,000 units per milliliter is stocked without the prior approval of the PT&N committee.

(d) Only Alaris® IV programmable infusion pumps using Guardrails software, or a comparable contracted product, will be used for administration of parenteral anticoagulants, including, but not limited to unfractionated heparin, argatroban, and bivalirudin.

(e) Anticoagulants are stored in automated dispensing devises where available. If multiple strengths or concentrations of the same anticoagulant are stored in the same automated dispensing device, they are stored in separate drawers and clearly labeled as high alert medications in according with NM 119-11-15, High Alert Medications.

(2) Processes are in place to minimize the risk associated with incorrect tablet strength dosing errors with warfarin.

(a) Each warfarin tablet strength is a separate orderable item in the CPRS electronic medical record ordering menu.

(b) The 5mg and 2mg strength tablets of warfarin are the primary, preferred strengths of warfarin dispensed by the outpatient anticoagulation clinic.

(3) Instructions for anticoagulants are clearly communicated on the prescription label.

(a) Outpatient prescriptions for warfarin will be labeled to avoid patient confusion.

(b) The statement, “or as directed,” will be included on outpatient prescription labels for warfarin written by clinical pharmacy specialists working in the outpatient anticoagulation clinic.

(4) VHA has established the potential for therapeutic differences between brands of warfarin.

(a) When warfarin is prescribed, one standard brand selected by the VHA PBM will be dispensed by MGVAMC pharmacy.

(b) It is recognized that some patients may request to purchase warfarin in the community at a lower cost than their VA copay. Patients may purchase generic warfarin prescribed by a VA provider, however if the VA provider determines that the generic product leads to erratic lab values, the provider may require the patient to purchase one brand of warfarin. Non-VA prescriptions for warfarin will be documented on the patients non-VA medication list.

g. Critical drug-drug interactions: Anticoagulation providers are available to support clinical decision making for critical drug-drug interactions.

(1) CPRS order checks: MGVAMC utilizes CPRS order checks to alert prescribers and pharmacists to critical drug-drug interactions between anticoagulants and other medications. It is the responsibility of the ordering provider to obtain the necessary information to evaluate the potential impact of the drug-drug interaction on the individual patient prior to completing the order. Critical drug-drug interactions alerts require provider review, justification, and signature to bypass.

(2) Prospective medication review and processing: Outpatient and inpatient clinical pharmacists complete prospective drug utilization review and processing prior to checking and dispensing new prescriptions. If a critical drug-drug interaction is flagged the pharmacist is required to review the order prior to dispensing. The pharmacist will assess the interaction and may recommend alternatives by directly contacting the ordering provider. If the impact of the drug-drug interaction will extend to the outpatient care of the patient, the prescriber will notify the patient’s anticoagulation provider of the potential drug-drug interaction to support patient safety and appropriate monitoring. Communication methods include anticoagulation electronic consult or direct communication with anticoagulation management program staff.

h. Risk-benefit assessment: Anticoagulation providers will collaborate with VA continuity of care providers to perform initial and periodic risk-benefit assessments for patients receiving anticoagulation therapy managed within the centralized outpatient anticoagulation management program. Components of the risk-benefit assessment include, but are not limited to:

(1) Patient adherence to therapy;

(2) Degree of control with warfarin, measured by proportion of values in therapeutic range;

(3) Risk of bleeding or any major changes to that risk;

(4) Changes in patient parameters such as kidney and/or liver function;

(5) Risk of thrombosis and any major changes to that risk; and

(6) Changes in general health, frailty, fall risk, and other possibly relevant considerations.

i. Patient education: Initial patient and family education provided by anticoagulation providers will be comprehensive. Ongoing education/re-education will be assessed by the anticoagulation provider and communicated to patient and family as determined to be necessary to support safe and effective care at subsequent visits. Recommended initial education will include:

(1) Indication for therapy;

(2) Interactions (drug, diet, and disease);

(3) Daily dosage;

(4) The importance of medication adherence;

(5) The management of missed doses;

(6) Signs and symptoms of bleeding and thromboembolic events, and what to do if such event occurs;

(7) The need to inform other health care providers about long-term anticoagulation therapy;

(8) The need to inform the anticoagulation provider when changes in medications occur or upcoming procedures are expected;

(9) Risks associated with falling;

(10) Proper tablet identification;

(11) Need to inform the anticoagulation provider about acute illness, major changes in diet, or upcoming travel (for warfarin);

(12) The dangers of using medication from various sources (especially for warfarin);

(13) Monitoring requirements, specifically for warfarin; and

(14) Proper medication storage, specifically for dabigatran.

j. Processes are in place to minimize patient loss to follow-up for outpatients and during times of transition from inpatient to outpatient care.

(1) Patients receiving long-term anticoagulants from MGVAMC on an ongoing basis from VA credentialed providers shall be consulted to the outpatient anticoagulation clinic for anticoagulation monitoring.

(a) Inpatients discharged on long-term anticoagulants will be consulted to the outpatient anticoagulation clinic for follow-up monitoring and medication management, as appropriate.

(b) Electronic consults will be used to communicate transitions of care during normal inpatient pharmacy business hours (Monday - Friday, 0800 - 1600). Patients discharged after hours or on the weekends will be identified by inpatient pharmacy staff for electronic consult on the next regular business day by assessing the VistA patient movement report.

(2) To support that outpatients receiving warfarin are not lost to follow-up (defined as follow-up assessment for INR > than 42 days from last visit) the quantity of warfarin provided with each prescription for non-anticoagulation providers will be limited to:

(a) VA continuity providers: 30 days, no refills, unless prescribing long-term anticoagulation in collaboration with anticoagulation management program for monitoring and quality assurance. Justified use will be documented in prescription comments.

(b) Credentialed VA providers (non-anticoagulation provider): 30 days, no refills.

k. Telephone access to outpatient anticoagulation providers:

(1) Clinical pharmacy specialists working in the outpatient anticoagulation clinic will be available during normal business hours, Monday - Friday, 0800 - 1600.

(a) The anticoagulation management program will have a direct telephone extension that is accessible to facility staff and anticoagulation patients. The phone number is (509) 434-7900.

1 Phone calls may be answered by ancillary staff for triage.

2 Calls requiring clinical decision making will be routed to an available anticoagulation provider.

(b) Voicemail is available for non-urgent questions and concerns during times of high call volume. Urgent callers will be alerted through voicemail message to seek urgent emergency care immediately. Routine phone messages will be checked at least twice daily.

(2) After hours: MGVAMC does not have a 24-hour outpatient access clinic. Urgent callers will be alerted through voicemail message to seek urgent emergency care immediately. Routine phone messages will be checked on the next normal business day.

l. Point of Care Testing (POCT): MGVAMC does not utilize POCT or patient self-testing for measuring the INR and management of anticoagulation. When POCT and/or patient self-testing is utilized in the future, a program will be developed within the medical center ancillary testing program to meet all required standards.

m. Choice: For Veterans with prescriptions authorized by the Choice third party administrator, the responsibility for patient level care management, monitoring laboratory requirements and initiation, adjustment and canceling of prescribed medications remains solely with the non-VA Choice prescriber. VA is operating like a “drug store” under Choice and therefore has more limited responsibilities than is the case when providing pharmacy services under VA’s comprehensive medical care system.

n. VA clinical pharmacists are not responsible for ordering laboratory tests or performing clinical pharmacy services beyond their professional expectation of reviewing, interpreting, and verifying medication orders for appropriateness.

o. The VA clinical pharmacist must not refer a patient to the pharmacy managed anticoagulation clinic when the patient’s anticoagulation care falls under the responsibility of a non-VA Choice prescriber.

5. RESPONSIBILITIES:

a. Medical Center Director and COS are responsible for ensuring:

(1) The medical center policy exists and meets standards identified in VHA Directive 1033.

(2) The medical center has an established anticoagulation management program for management of inpatients and outpatients on anticoagulants.

(3) An anticoagulation program manager and an anticoagulation physician champion have been designated to support MGVAMC’s anticoagulation management program.

(4) Adequate staff-to-patient ratios and resources are allotted for the anticoagulation management program, as appropriate, to maximize operational efficiency.

(5) Promoting medical staff adherence to anticoagulation program policies and processes.

b. Clinical service chiefs are responsible for notifying their respective staff prescribers of responsibility/accountability for the therapeutic use of anticoagulants within their scope of practice.

c. Anticoagulation program physician champion is responsible for:

(1) Providing consultation to anticoagulation program staff and working collaboratively as an advocate for the anticoagulation program.

(2) Supporting anticoagulation initiatives at the facility level.

(3) Reviewing anticoagulation program policies and procedures, medication protocols, guidelines, and resources.

d. Pharmacy Service Chief is responsible for ensuring:

(1) A clinical pharmacist anticoagulation provider is identified as the pharmacy anticoagulation management champion to be actively involved in defined components of the anticoagulation program.

(2) The number of concentrations and quantities of heparin vials stocked in patient care and procedural areas are limited to the minimum needed to meet patient care needs.

(3) Safe storage of anticoagulants in automated dispensing devices. If multiple strengths or concentrations of the same anticoagulant are stored in the same automated dispensing device, they need to be stored in separate drawers (or single access cubie) and clearly labeled as high alert medications.

(4) Direct oversight of the pharmacy anticoagulation management program.

(5) Ensuring competencies specific for anticoagulant therapy management are included in the competency plans and assessed routinely for clinical pharmacy specialists involved in managing anticoagulation therapy. Competency assessment will be facilitated through the initial and ongoing professional practice evaluation program for initial and ongoing competency.

(6) Reviewing anticoagulant medication management protocols, anticoagulation program guidelines and resources.

(7) Providing adequate staffing to meet program needs.

e. Anticoagulation program manager is responsible for:

(1) Oversight for policy and maintains an ongoing quality assurance plan to identify practice improvements, ensure appropriate action is taken to improve practices and measure the effectiveness of those actions on a regular basis.

(2) Conducting initial and ongoing competency assessments for anticoagulation providers and anticoagulation support staff, and coordinates anticoagulation education for clinical staff directly involved in caring for patients receiving anticoagulation therapy.

(3) Anticoagulation related SOPs, algorithms, and practice guidelines will be continuously reviewed by the anticoagulation program manager and updated, at a minimum, every three years, or more frequently, as appropriate, based on the most recent evidence based recommendations. Proposed revisions will be vetted and approved through the PT&N committee and CEC for concurrence prior to implementation.

(4) Developing MGVAMC’s policy related to use of anticoagulants. This encompasses policies to govern practice within the anticoagulation management program, but may also include policies relating to the use of anticoagulants in other areas (e.g., surgical or specialty areas).

(5) Promoting learning and unified practice for the anticoagulation management program through activities such as educational initiatives, regular staff meetings, and journal clubs.

(6) Coordinating and reporting quality assurance activities and results for the anticoagulation management program through the PT&N Committee and CEC, as appropriate.

(7) Ensuring availability of appropriate patient education materials, as applicable.

(8) Conducting anticoagulation policy compliance audits periodically and reporting deficiencies to PT&N Committee and CEC as applicable for discussion and follow-up action.

f. Anticoagulation providers are responsible for:

(1) Managing routine anticoagulation therapy for patients enrolled in the inpatient and outpatient settings according to approved guidelines and protocols.

(2) Maintaining knowledge of most recent guidelines for the use of anticoagulants published by the American College of Chest Physicians, including:

(a) Goals of therapy;

(b) Criteria for use of individual anticoagulants;

(c) Standard dosing and monitoring requirements;

(d) Common adverse effects;

(e) Common drug-drug and drug-disease interactions; and

(f) Recommendations for periprocedural adjustments to therapy.

(3) Collaboration with consulting providers to:

(a) Determine a patient-specific plan for anticoagulation, including referred drug/dose and duration of use, based on the individual patient’s comorbidities, home context, risk versus benefit of anticoagulation, likelihood of safe use of anticoagulation, and anticipated adherence to follow up. This plan shall be documented clearly in the patient’s electronic health record for other providers to see.

(b) Plan interruptions of anticoagulation or dose adjustment as necessary in response to changes in the patient’s clinical status, medication regimen, or plans for invasive procedures.

(c) Devise an appropriate, patient-specific course of action when a patient fails to adhere to the anticoagulation program treatment agreement.

(d) Seek input from continuity and/or prescribing providers when questions or concerns about anticoagulation plans arise.

(4) Delivery of initial and ongoing patient and family education that includes the importance of follow-up monitoring, compliance issues, dietary restrictions, and potential for adverse drug reactions and interactions.

(5) Conduct appropriate and periodic risk-benefit assessments for all patients receiving anticoagulant therapy and communicating recommendations to the original referring provider and/or PACT provider as appropriate.

(6) Perform and/or facilitate the day-to-day operations of the anticoagulation management program.

(7) Report ADE, close calls, and any unsafe conditions of which they are aware.

(8) Oversee pharmacists and pharmacy trainees involved in anticoagulant monitoring who do not have a scope of practice and competencies in anticoagulation.

(9) Support transitions of care for patients prescribed anticoagulants across the continuum of care.

g. Anticoagulation support staff are responsible for answering and triaging patient telephone calls, contacting patients who have missed appointments, sending letters to patients, communicating with outside laboratories, scheduling appointments, and other similar tasks.

h. Chief, Nutrition and Food Services is responsible for ensuring:

(1) Warfarin is included in Nutrition and Food Services' established food and medication interaction program.

(2) A process is established to notify Nutrition and Food Services of patients receiving meal services that are also receiving warfarin therapy. Nutrition and Food Services responds according to its established food and medication interaction program to patients receiving meal services and warfarin therapy. Meal planning and educational efforts are focused on steady vitamin K intake, individualized to meet the overall health needs, and supporting an adequate dietary reference intake for vitamin K.

(3) Inpatients on oral anticoagulation or newly started on oral anticoagulation therapy will be referred to a dietitian by the hospitalist for dietary counseling and meal adjustments, as necessary.

i. Chief, Pathology and Laboratory Medicine is responsible for ensuring:

(1) The correct ISI value for the lot number of thromboplastin, currently in use, is entered into the coagulation testing instrumentation.

(2) There is documentation of periodic monitoring to ensure the entered value remains accurate.

(3) The correct geometric mean PT is calculated for the current lot number of thromboplastin and is entered into the coagulation testing instrumentation as required for calculation of the INR. The geometric mean PT needs to be recalculated with each change of lot number of thromboplastin reagent.

(4) The availability of reliable testing of heparin levels (factor Xa levels), heparin associated antibodies and a serotonin release assay for the evaluation of heparin induced thrombocytopenia.

(5) The availability of appropriate laboratory tests for DOAC in special situations (e.g., suspected overdose, bleeding, urgent procedure, etc.).

(6) Educating staff providing clinical services in an outpatient anticoagulant clinic and staff involved in home anticoagulation therapy management on national and local laboratory policies.

j. Chief nursing executive or designee is responsible for:

(1) Ensuring initial nursing staff competency for therapeutic use of anticoagulants.

(2) Ensuring the administration of heparin intravenous admixture is done using the pre-programmed heparin protocol in the Alaris® pump.

(3) Ensuring initial competency is established for all nurses given responsibility to dose and monitor heparin and other anticoagulants per protocol.

(4) Ensuring that nurses are aware of the nursing role in MGVAMC’s approved protocols/procedures for heparin, and the monitoring of the patient when other anticoagulants are used.

(5) Maintenance of self-knowledge to administer anticoagulants, monitor, and have roles in anticoagulation protocols.

k. Continuity VA provider and prescribing VA providers are responsible for:

(1) Maintaining knowledge of most recent guidelines for the use of anticoagulants published by the American College of Chest Physicians, including:

(a) Goals of therapy;

(b) Criteria for use of individual anticoagulants;

(c) Standard dosing and monitoring requirements;

(d) Common adverse effects;

(e) Common drug-drug and drug-disease interactions; and

(f) Recommendations for periprocedural adjustments to therapy.

(2) Understanding eligibility criteria for consultation to the anticoagulation management program.

(3) Proper use of the anticoagulation management program consults and anticoagulant drug order menus to support anticoagulant use follows protocols and processes based on indication and setting. Deviation from standard use is discouraged and must be documented clearly in the medical record.

(4) Collaboration with anticoagulation providers to:

(a) Determine a patient-specific plan for anticoagulation, including preferred drug/dose and duration of use, based on the individual patient’s comorbidities, home context, risk versus benefit of anticoagulation, likelihood of safe use of anticoagulation, and anticipated adherence to follow up. This plan shall be documented clearly in the patient's electronic health record for other providers to see.

(b) Communicate changes in the patient’s clinical status, medication regimen, or plans for invasive procedures that may warrant interruption in anticoagulation or dose adjustment.

(c) Advice regarding the need for bridging therapy when oral anticoagulation must be interrupted or when levels are sub-therapeutic.

(d) Assist with the evaluation and management of patients with supra-therapeutic INR or complications related to anticoagulation therapy.

(e) Devise an appropriate, patient-specific course of action when a patient fails to adhere to the anticoagulation management program treatment agreement.

(5) Adding the appropriate international classification of diseases (ICD) diagnosis codes or appropriate systematized nomenclature of medicine-clinical term (SNOMED-CT) codes, as applicable, to the problem list of patients on long-term anticoagulation therapy.

(6) Consultation of subspecialty providers, including hematology or cardiology, when additional expertise is indicated to guide anticoagulation plans.

(7) Communication with other VA and non-VA providers involved in a patient’s care to ensure status of anticoagulation is understood clearly at the time of handoff, including transitions from hospital or nursing home.

(8) Education of Veterans regarding the potential risks and benefits of anticoagulation in their specific circumstances.

(9) Oversight of residents prescribing and administering anticoagulant therapies under their supervision.

(10) Support transitions of care for patients prescribed anticoagulants across the continuum of care.

6. REFERENCES:

· Evidence-Based Management of Anticoagulant Therapy: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence -Based Clinical Practice Guidelines

· VHA Directive 1033, Anticoagulation Therapy Management, dated July 29, 2015

· VHA Directive 1138.01, Patient Self-Testing for Monitoring of Prothrombin Time International Normalized Ratio (INR) In Patients on Warfarin Anticoagulation Therapy, dated May 12, 2015

· VHA Directive 1088, Communicating Test Results to Providers and Patients, dated October 7, 2015

· VHA Handbook 1108.11, Clinical Pharmacy Services, dated July 1, 2015, updated June 29, 2017

· The Joint Commission, National Patient Safety Goals, NPSG 03.05.01 Current edition Comprehensive Accreditation Manual for Hospitals, Joint Commission

· Dipiro JT, et al. Pharmacotherapy: A Pathophysiologic Approach. McGraw Hill.

10th edition. 2017

· VHA Handbook 1101.11, Coordinated Care for Traveling Veterans, dated April 22, 2015

· NM 119-24-16, Pharmacists Support for Traveling Veterans, dated February 9,

· University of Washington Anticoagulation Services

· Patient Care Services SharePoint

· Pharmacy Service SharePoint

7. RESCISSION: NM 119-30-16, dated June 27, 2016

8. FOLLOW-UP RESPONSIBILITY: Chief, Pharmacy Service (119)

//signed// Robert J. Fischer, MD Medical Center Director

Distribution: All services via Outlook

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